The FDA’s fiscal year 2022 report on the State of Pharmaceutical Quality also flagged a spike in inspections, non-compliant products and import alerts.
Pictured: Blue FDA sign on a white background/iStock
In fiscal year 2022, the FDA recorded a notable increase in registered manufacturing sites, as well as a spike in product recalls, warning letters issued and surveillance inspections, according to the regulator’s annual Report on the State of Pharmaceutical Quality.
The report is produced by the Office of Pharmaceutical Quality, under the FDA’s Center for Drug Evaluation and Research. The report for fiscal year 2022 (FY22)—from October 1, 2021 to September 30, 2022—is the fifth annual edition.
In FY22, the FDA issued a total of 912 recalls across 166 manufacturing sites, mostly for violating current good manufacturing practices (CGMP). This represents the highest number of recalls in five years.
The FDA’s report identified four specific events that contributed to most of the product recalls: temperature abuse, keeping the product outside its appropriate storage temperature, CGMP errors and contaminations. Respiratory tract agents were the most recalled products in 2022, followed by cardiovascular agents.
In FY22, the FDA counted 4,814 registered manufacturing sites, representing a 12% increase from 2018, of which 60% were producing products with approved Biologics License and New Drug Applications.
Most of the production facilities are in the U.S., though a substantial number are overseas, mostly in India, China and Germany, as well as in Canada.
Along with this growth in manufacturing sites, the FDA reported a drastic increase in surveillance inspection, conducting 328 of these operations in 2022. This is “nearly triple the amount” of inspections during the year prior, indicating that the regulator is starting to regain its pre-pandemic activity levels.
The FDA also issued 28 import alerts and 72 warning letters in FY22. Import alerts allow the regulator’s field staff to detain products coming from certain importers even without a physical examination at the time of entry. These alerts are issued after the FDA has gathered enough evidence to show that the product, its manufacturer or shipper could be in violation of regulatory laws or policies.
Most of the import alerts flagged Chinese and South Korean manufacturers, accounting for 43% and 36%, respectively.
The FDA’s sampling and testing program further found that of 1,552 samples tested, 57.5% or 892 were non-compliant with policies and quality controls; 592 of these non-compliant products were imported.
Meanwhile, most of the warning letters were issued to manufacturers of hand sanitizers. In 14 cases, methanol contamination was the sole reason for the CGMP violation.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
